Flaws in methods of evidence-based medicine may adversely affect public health directives

It is inappropriate to randomize treatments acknowledged to have different safety and quality-of-life outcomes.AndEvidence from such randomization is both scientifically and ethically flawed.AndPublic health policies or directives based on flawed evidence may affect public health adversely.ThereforeEvidence- based medicine studies founded on inappropriate randomization have resulted in underutilization of the most effective and durable treatment of obesity. In evidence-based medicine (EBM), the "gold standard" for strength of evidence is the randomized controlled trial, an important method in pharmacotherapy but with serious limitations when applied to invasive treatments such as surgery. These limitations are particularly obvious in the case of the rapidly expanding field of bariatric surgery. Flawed practice guidelines emanating from EBM studies lacking true peer review and based on inappropriate criteria for evaluating surgical treatment contribute to underutilization of the most effective and durable therapy for severe obesity. Here we provide constructive recommendations for criteria in evaluation of surgical methods in general. We also criticize recent "authoritative" EBM reports and present extensive "evidence" for the efficacy of the only durable treatment for a serious, prevalent disease afflicting all strata of populations worldwide. © 2005 Elsevier Inc. All rights reserved.